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Tests treatment safety and results for ANCA Associated Vasculitis
Official title Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
ClinicalTrials.gov ID: NCT05962840
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anca associated vasculitis.
Also referred to as Taiai for commercial name.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients age 18 to 65 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR...
- Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
- Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
You likely can't join if
- Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
- Patients who had other autoimmune diseases.
- Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD...
- Patients who are pregnant or have planned for pregnancy in next 2 years.
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.
- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.
See the full eligibility criteria
- Patients age 18 to 65 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
- Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
- Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
- Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
- Patients who had other autoimmune diseases.
- Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR\<30ml/min).
- Patients who are pregnant or have planned for pregnancy in next 2 years.
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.
- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.
- Patients with malignancy.
- Patients who are not eligible according to the judge of the principal investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.